Back to results

Microarchitecture of Vitreoretinal Contact

Primary Purpose

Vitreoretinal Detachment, Vitreo-Retinal Adhesion

Status

Completed

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

scanning electron microscopy

About this trial

This is an interventional basic science trial for Vitreoretinal Detachment focused on measuring internal limiting membrane, human vitreous, vitreomacular adhesion, vitreoretinal contact, vitreoretinal interface, hyalocytes, collagen

Eligibility Criteria

35 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

eyes from donors without concomitant multiple organ pathology and ophthalmic pathology

Exclusion Criteria:

eye injury, age over 45 years, concomitant multiple organ pathology, previous eye diseases

Sites / Locations

S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cadaver eyes

Arm Description

The Central region of the retina and preretinal structures of cadaver eyes are examined

Outcomes

Primary Outcome Measures

the ILM thickness in the macular zone (foveola)

the ILM thickness in the macular zone (foveola) in mkm by scanning electron microscopy data

superficial microstructure of ILM

by scanning electron microscopy data

features of the structural microarchitecture of the preretinal vitreous in the macular zone

by scanning electron microscopy data

morphofunctional features of preretinal hyalocytes.

by scanning electron microscopy data

Secondary Outcome Measures

Full Information

NCT ID

NCT04802889

First Posted

December 6, 2020

Last Updated

March 15, 2021

Sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

1. Study Identification

Unique Protocol Identification Number

NCT04802889

Brief Title

Microarchitecture of Vitreoretinal Contact

Official Title

Microarchitecture of Vitreoretinal Contact

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2008 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Investigation of the vitreoretinal contact microarchitecture in the macular and paramacular zones of the human retina.

Detailed Description

Purpose: to study the features of the macular ILM, to study the features of the preretinal structures of the vitreous body of the Central retinal region, morphofunctional features of preretinal hyalocytes, and the mechanism of vitreoretinal adhesion. Study Protocol: examination of donor human eyes obtained from an eye Bank after sampling material for corneal transplantation. Research method: scanning electron microscopy (SEM) of the central retina (macular and paramacular zone): ILM, preretinal vitreous. Scientific hypothesis: vitreoretinal adhesion is provided not by laminin and fibronectin, but by the interweaving of vitreous collagen fibers between the epiretinal vitreous (more firmly fixed to the retinal surface) and the cortical vitreous. Expected results: determination of ILM thickness in the macular zone, microanatomy of preretinal vitreous strutcures, and possible mechanism of vitreoretinal adhesion, establishing the possibility of intravital synthesis of collagen fibers synthesis in the adult vitreous.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitreoretinal Detachment, Vitreo-Retinal Adhesion

Keywords

internal limiting membrane, human vitreous, vitreomacular adhesion, vitreoretinal contact, vitreoretinal interface, hyalocytes, collagen

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cadaver eyes

Arm Type

Experimental

Arm Description

The Central region of the retina and preretinal structures of cadaver eyes are examined

Intervention Type

Other

Intervention Name(s)

scanning electron microscopy

Intervention Description

scanning electron microscopy of the сentral retina and preretinal structures

Primary Outcome Measure Information:

Title

the ILM thickness in the macular zone (foveola)

Description

the ILM thickness in the macular zone (foveola) in mkm by scanning electron microscopy data

Time Frame

within 3 days after receiving the cadaver eyes

Title

superficial microstructure of ILM

Description

by scanning electron microscopy data

Time Frame

within 3 days after receiving the cadaver eyes

Title

features of the structural microarchitecture of the preretinal vitreous in the macular zone

Description

by scanning electron microscopy data

Time Frame

within 3 days after receiving the cadaver eyes

Title

morphofunctional features of preretinal hyalocytes.

Description

by scanning electron microscopy data

Time Frame

within 3 days after receiving the cadaver eyes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: eyes from donors without concomitant multiple organ pathology and ophthalmic pathology Exclusion Criteria: eye injury, age over 45 years, concomitant multiple organ pathology, previous eye diseases

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pavel V Lyskin, PhD

Organizational Affiliation

The S.N. Fyodorov Eye Microsurgery State Institution

Official's Role

Principal Investigator

Facility Information:

Facility Name

S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"

City

Moscow

ZIP/Postal Code

127486

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://kazanmedjournal.ru/kazanmedj/article/viewFile/15523/12127

Description

Microanatomy of vitreoretinal interactions in macular and paramacular areas (article DOI: 10.17816/KMJ2019-595)

URL

https://doi.org/10.25276/0235-4160-2019-1-39-43

Description

Microanatomy of Internal Limiting Membrane (article)

URL

https://doi.org/10.25276/2307-6658-2019-2-52-56

Description

Cellular Microanatomy of Vitreoretinal Interface. Morphofunctional Identification of Epiretinal Vitreous Cells. Collagen Synthesis in Adult Human Vitreous (article)

URL

https://doi.org/10.25276/2307-6658-2019-2-57-62

Description

New Data of Mechanism in Vitreoretinal Adhesion and Posterior Vitreous Detachment in Humans (article)

URL

https://doi.org/10.25276/2307-6658-2018-4-27-32

Description

Antithesis to the thesis about fibronectin and laminin as the main components providing vitreoretinal adhesion (article)

Learn more about this trial

Microarchitecture of Vitreoretinal Contact

We'll reach out to this number within 24 hrs